Medipixel XA-Assisted Percutaneous Coronary Intervention in Coronary Artery Disease: A Prospective Multicenter Study

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This prospective, multicenter, single-arm, interventional study evaluates the effectiveness and safety of Medipixel XA-Assisted Percutaneous Coronary Intervention (MPXA-PCI) in patients with coronary artery disease (CAD). The study aims to assess procedural success rates and clinical outcomes associated with the novel MPXA-assisted PCI strategy in a real-world clinical setting. A total of 830 patients with de novo coronary lesions eligible for drug-eluting stent (DES) implantation will be enrolled. All participants will undergo MPXA-assisted lesion assessment to optimize balloon and stent selection. The primary outcome is target vessel failure (TVF) at 12 months, defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. Secondary outcomes include procedural success, angiographic results, and periprocedural complications. This study will provide evidence regarding the clinical applicability and safety of artificial intelligence-assisted quantitative coronary analysis (AI-QCA) technology for optimizing PCI procedures.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Silent ischemia, stable or unstable angina, or myocardial infarction

• De novo coronary lesion eligible for DES implantation

• Lesions analyzable by MPXA

Locations
Other Locations
Republic of Korea
Keimyung University Dongsan Medical Center
RECRUITING
Daegu
Chonnam National University Hospital
RECRUITING
Gwangju
Chung-Ang University Gwangmyeong Hospital
RECRUITING
Gwangmyeong
Presbyterian Medical Center
RECRUITING
Jeonju
CHA Bundang Medical Center
RECRUITING
Seongnam-si
Ulsan University Hospital
RECRUITING
Ulsan
Contact Information
Primary
Hwa-In Kim
niawhz23@gmail.com
+82-31-780-5858
Backup
Seung-Yul Lee
seungyul79@gmail.com
+82-31-780-5858
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2028-05
Participants
Target number of participants: 830
Treatments
Experimental: Medipixel XA-Assisted PCI Group
Sponsors
Leads: CHA University

This content was sourced from clinicaltrials.gov